Oxytocin and mother-infant interaction

• Register: EUCTR
• Last refreshed on: 19 January 2015
• Main ID: EUCTR2014-005431-13-FI
• Date of registration: 15/12/2014
• Prospective Registration: Yes
• Primary sponsor: Tampere University Hospital
• Public title: Oxytocin and mother-infant interaction
• Scientific title: Effects of maternal oxytocin on social information processing in mothers and infants
• Date of first enrolment: 13/01/2015
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005431-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Finland

Contacts

• Name: TACC/Kaija Puura
• Affiliation: Tampere University Hospital

• Name: TACC/Kaija Puura
• Affiliation: Tampere University Hospital

Key inclusion & exclusion criteria

Inclusion criteria:
In order to be eligible to participate in this study, a subject must meet
the following criteria:
Mothers: healthy female subjects, 20-40 years old, mothers of children
younger than 9 months
Children: healthy infants, approximately 9 months old during
the first laboratory visit
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
A potential subject who meets any of the following criteria during a
telephone prescreening will be excluded from participation in this study:
-Breastfeeding
-Any known neurological, visual, and auditory impairment
-Use of medication (except oral contraceptives)
-Drug or alcohol abuse
-Psychiatric disorder
-Nasal disease or obstruction
-Smoking
-Pregnancy
-Cardiovascular disease

For the children:
-Premature birth (<37 weeks)
-Low birth weight (<2500 g)
-Diagnosis of a neurological or visual disorder


Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

There are no medical conditions or diseases under investigation, participants are healthy volunteers.

Therapeutic area: Not possible to specify

Intervention(s)

Trade Name: Syntocinon
Product Name: Syntocinon
Pharmaceutical Form: Nasal spray
Pharmaceutical form of the placebo: Nasal spray
Route of administration of the placebo: Nasal use

Primary Outcome(s)

Main Objective: The primary objectives of the study are to study the effects of intranasal OT (vs. placebo) administration to mothers on:
1. Mothers' observed interaction behavior
2. Children's sensitivity to the emotional signals of others (via OT-induced effects on mothers' interactive behavior)

Secondary Objective: The secondary objective of the study is to study the effects of intranasal OT (vs. placebo) administration to mothers on specific facets of interactive behaviors with one's own child

Primary end point(s): -Maternal sensitivity scores on the Emotional Availability Scales during
mother-child free play
-Infant saccadic responses to peripheral visual stimuli in the eyetracking
paradigm

Timepoint(s) of evaluation of this end point: Participants will come to the laboratory for two identical experimental
sessions, separated by 4 weeks.

Secondary Outcome(s)

Secondary end point(s): -Maternal responses in the focal interaction tasks (indicating contingent
responsiveness, responses to joint attention cues, and emotionregulatory
behaviors)

Timepoint(s) of evaluation of this end point: Secondary parameters will be assessed during the same two identical
experimental sessions, separated by 4 weeks.

Secondary ID(s)

OTMother2015

Source(s) of Monetary Support

Academy of Finland